IMUNON Confirms Database Lock for Phase 2 OVATION 2 Study on IMNN-001 in Advanced Ovarian Cancer

IMUNON, Inc., a clinical-stage company focused on advanced non-viral DNA-mediated immunotherapies, has announced the database lock for its Phase 2 OVATION 2 Study which evaluates the safety and efficacy of IMNN-001 in advanced ovarian cancer patients. The study has reached its required median Overall Survival (OS) and Progression Free Survival (PFS) milestones, with all patients achieving the mandated 16-month treatment observation period. Independent statisticians will now analyze the raw trial data, and IMUNON expects to report topline results, including hazard ratios, by the end of July 2024.

The OVATION 2 Study examines the dosing, safety, efficacy, and biological activity of intraperitoneal administration of IMNN-001 combined with neoadjuvant chemotherapy (NACT) in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The approach is designed to shrink tumors significantly during the neoadjuvant period to optimize surgical removal following three cycles of chemotherapy. Post-surgery, patients receive three additional cycles of adjuvant chemotherapy. The study involves a 1:1 randomization to compare the outcomes of NACT plus IMNN-001 versus standard NACT. Patients in the IMNN-001 treatment arm received up to 17 doses of 100 mg/m² in addition to NACT. Full enrollment of 110 patients was achieved in September 2022.

The primary goal of the OVATION 2 Study is to inform the design of a forthcoming Phase 3 trial. Hence, it is not statistically powered for significance. The primary efficacy analysis will be based on the Intent to Treat (ITT) population as per the Statistical Analysis Plan (SAP). The primary endpoint is Progression Free Survival (PFS), with secondary endpoints including Overall Survival (OS), Objective Response Rate, Chemotherapy Response Score, and Surgical Response.

Stacy Lindborg, Ph.D., president and CEO of IMUNON, highlighted that reaching the data lock for OVATION 2 is a significant milestone for the team and aligns with their mission to provide innovative treatments for ovarian cancer patients. With the absolute last patient enrolled in September 2022, the ITT population analysis will now provide robust data for evaluating PFS and OS. Lindborg expressed optimism that IMNN-001 may offer improved outcomes and serve as a much-needed alternative therapy for those afflicted by this severe disease.

Sebastien Hazard, M.D., Ph.D., chief medical officer of IMUNON, emphasized the critical importance of OS in the trial's readout and its implications for planning the Phase 3 trial. OS, as the definitive endpoint, is seen as the most indicative of long-term benefits of immunotherapies across various tumor types. The team looks forward to sharing the trial outcomes with the patient and medical community.

IMNN-001 is designed using IMUNON's TheraPlas® platform technology, which encapsulates an interleukin-12 (IL-12) DNA plasmid vector in a nanoparticle delivery system. This facilitates cell transfection followed by sustained local secretion of the IL-12 protein, a potent cytokine that induces significant anticancer immunity through the proliferation of T-lymphocytes and natural killer cells. IMUNON has previously reported positive safety outcomes and encouraging Phase 1 results with IMNN-001, both as monotherapy and in combination with other treatments in advanced ovarian cancer patients. The company also completed a Phase 1b dose-escalation trial (OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in newly diagnosed ovarian cancer patients.

Epithelial ovarian cancer is one of the deadliest cancers among women in the United States, with approximately 22,000 new cases annually. Most cases are diagnosed at advanced stages (III/IV), and the disease is characterized by high recurrence rates and poor five-year survival rates for these stages. There is a pressing need for therapies that improve overall survival and reduce recurrence rates, making the peritoneal cavity an attractive target for regional immune modulation in advanced ovarian cancer patients.

IMUNON focuses on developing innovative treatments that harness the body's natural mechanisms for a broad array of diseases. The company's TheraPlas® technology is aimed at coding cytokines and therapeutic proteins for treating solid tumors with promising immunological approaches. IMUNON's lead program, IMNN-001, represents a significant advancement in localized treatment for advanced ovarian cancer, instructing the body to produce cancer-fighting molecules at the tumor site. The company continues to explore the therapeutic potential of plasmid DNA to serve patients with challenging conditions.